National Tunisian Multicenter Prospective Study on Cardiac Implantable Electronic Devices (Tunisian NATURE-CIED study): One-year complications and predictive factors
Background: The prevalence of cardiac implantable electronic devices (CIEDs) in Tunisia is rising because of increased life expectancy and broader indications. This has led to a higher incidence of complications related to vascular access, device pockets, leads, and patient characteristics. Objectiv...
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Elsevier
2025-08-01
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| Series: | Heart Rhythm O2 |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2666501825001540 |
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| author | Sonia Chabrak, MD Emna Allouche, MD Sana Ouali, MD Abdeddayem Haggui, MD Afef Ben Halima, MD Slim Kacem, MD Salma Krichen, MD Sonia Marrakchi, MD Wafa Fehri, MD Mohamed Sami Mourali, MD Zeineb Jabbari, MD Manel Ben Halima, MD Elyes Neffati, MD Aymen Heraiech, MD Mehdi Slim, MD Salem Kachboura, MD Habib Gamra, MD Majed Hassine, MD Sondes Kraiem, MD Sofien Kammoun, MD Leila Bezdah, MD Gouider Jridi, MD Hatem Bouraoui, MD Rania Hammami, MD Rafik Chettaoui, MD Youssef Ben Ameur, MD Fares Azaiez, MD Rami Tlili, MD Kais Battikh, MD Hedi Ben Slima, MD Rim Chrigui, MD Samia Fazaa, MD Islem Sanaa, MD Yassine Ellouz, MD Mohamed Mosrati, MD Sami Milouchi, MD Soumaya Jarmouni, MD Wacef Ayadi, MD Malek Akrout, MD Rabie Razgallah, MD Wissal Neffati, MD Meriem Drissa, MD Selma Charfeddine, MD Leila Abid, MD Lilia Zakhama, MD Salem Abdessalem, MD |
| author_facet | Sonia Chabrak, MD Emna Allouche, MD Sana Ouali, MD Abdeddayem Haggui, MD Afef Ben Halima, MD Slim Kacem, MD Salma Krichen, MD Sonia Marrakchi, MD Wafa Fehri, MD Mohamed Sami Mourali, MD Zeineb Jabbari, MD Manel Ben Halima, MD Elyes Neffati, MD Aymen Heraiech, MD Mehdi Slim, MD Salem Kachboura, MD Habib Gamra, MD Majed Hassine, MD Sondes Kraiem, MD Sofien Kammoun, MD Leila Bezdah, MD Gouider Jridi, MD Hatem Bouraoui, MD Rania Hammami, MD Rafik Chettaoui, MD Youssef Ben Ameur, MD Fares Azaiez, MD Rami Tlili, MD Kais Battikh, MD Hedi Ben Slima, MD Rim Chrigui, MD Samia Fazaa, MD Islem Sanaa, MD Yassine Ellouz, MD Mohamed Mosrati, MD Sami Milouchi, MD Soumaya Jarmouni, MD Wacef Ayadi, MD Malek Akrout, MD Rabie Razgallah, MD Wissal Neffati, MD Meriem Drissa, MD Selma Charfeddine, MD Leila Abid, MD Lilia Zakhama, MD Salem Abdessalem, MD |
| author_sort | Sonia Chabrak, MD |
| collection | DOAJ |
| description | Background: The prevalence of cardiac implantable electronic devices (CIEDs) in Tunisia is rising because of increased life expectancy and broader indications. This has led to a higher incidence of complications related to vascular access, device pockets, leads, and patient characteristics. Objective: We aimed to evaluate the prevalence, types, and predictors of complications occurring within the first year after CIED implantation and to profile the demographic and epidemiologic characteristics of CIED recipients in Tunisia. Methods: The National Tunisian Multicenter Prospective Study on Cardiac Implantable Electronic Devices is a nationwide, prospective study. We enrolled consecutive patients, from January 2021 to February 2022, undergoing de novo implantation of pacemakers, implantable cardioverter defibrillators, cardiac resynchronization therapy devices, generator replacements, and upgrading procedures. Patients attended 4 follow-up visits within the first year. Results: We enrolled 1500 patients with a mean age of 70.1 ± 15.2 years. Most (86.5%) received conventional pacemakers. The overall complication rate was 8.6%, with 129 complications in 80 patients. No significant associations were found between age or gender and complication rates. However, overweight and obesity were independent predictors of overall complications. Procedures performed in private health care settings were associated with a 56.2% reduction in complication rates. Generator replacements were linked to a 64.2% decrease in complication rates. Conversely, urgent or out-of-hours procedures increased the risk of complications by 62.7%. Procedures performed by non-electrophysiologist implanters were associated with an 89.5% increase in overall complication rates. Conclusion: Complications were more prevalent with cardiac resynchronization therapy devices. Identifying specific procedural predictors may pinpoint patients at higher risk, affecting personalized treatments and CIED implantation strategies. |
| format | Article |
| id | doaj-art-11e91ac9a5f941a29ab0cc09cd1e42a0 |
| institution | Kabale University |
| issn | 2666-5018 |
| language | English |
| publishDate | 2025-08-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Heart Rhythm O2 |
| spelling | doaj-art-11e91ac9a5f941a29ab0cc09cd1e42a02025-08-24T05:14:42ZengElsevierHeart Rhythm O22666-50182025-08-01681077108710.1016/j.hroo.2025.05.004National Tunisian Multicenter Prospective Study on Cardiac Implantable Electronic Devices (Tunisian NATURE-CIED study): One-year complications and predictive factorsSonia Chabrak, MD0Emna Allouche, MD1Sana Ouali, MD2Abdeddayem Haggui, MD3Afef Ben Halima, MD4Slim Kacem, MD5Salma Krichen, MD6Sonia Marrakchi, MD7Wafa Fehri, MD8Mohamed Sami Mourali, MD9Zeineb Jabbari, MD10Manel Ben Halima, MD11Elyes Neffati, MD12Aymen Heraiech, MD13Mehdi Slim, MD14Salem Kachboura, MD15Habib Gamra, MD16Majed Hassine, MD17Sondes Kraiem, MD18Sofien Kammoun, MD19Leila Bezdah, MD20Gouider Jridi, MD21Hatem Bouraoui, MD22Rania Hammami, MD23Rafik Chettaoui, MD24Youssef Ben Ameur, MD25Fares Azaiez, MD26Rami Tlili, MD27Kais Battikh, MD28Hedi Ben Slima, MD29Rim Chrigui, MD30Samia Fazaa, MD31Islem Sanaa, MD32Yassine Ellouz, MD33Mohamed Mosrati, MD34Sami Milouchi, MD35Soumaya Jarmouni, MD36Wacef Ayadi, MD37Malek Akrout, MD38Rabie Razgallah, MD39Wissal Neffati, MD40Meriem Drissa, MD41Selma Charfeddine, MD42Leila Abid, MD43Lilia Zakhama, MD44Salem Abdessalem, MD45Cardiology Department, Pasteur Clinic, Tunis, TunisiaCardiology Department, Faculty of Medicine of Tunis, Charles Nicolle Hospital, University of Tunis, Tunis, Tunisia; Address reprint requests and correspondence: Dr Emna Allouche, Cardiology Department, Faculty of Medicine of Tunis, Charles Nicolle Hospital, University of Tunis, Tunis, Tunisia.Cardiology Department, Faculty of Medicine of Tunis, La Rabta Hospital, University of Tunis, Tunis, TunisiaCardiology Department, Military Hospital, Faculty of Medicine of Tunis, University of Tunis, Tunis, TunisiaAbderrahmen Mami Hospital, Faculty of Medicine of Tunis, University of Tunis, Tunis, TunisiaCardiology Department, Essalem Center, Sousse, TunisiaCardiology Department, Bassetine Clinic, Sfax, TunisiaCardiology Department, Versailles Cardiology Center, Paris, FranceCardiology Department, Military Hospital, Faculty of Medicine of Tunis, University of Tunis, Tunis, Tunisia; Cardiology Department, Hospital of the Interior Force Security, University of Tunis, Tunis, TunisiaCardiology Department, Faculty of Medicine of Tunis, La Rabta Hospital, University of Tunis, Tunis, TunisiaCardiology Department, Faculty of Medicine of Tunis, La Rabta Hospital, University of Tunis, Tunis, TunisiaCardiology Department, Faculty of Medicine of Tunis, La Rabta Hospital, University of Tunis, Tunis, TunisiaCardiology Department, Faculty of Medicine of Sousse, Sahloul Hospital, University of Sousse, Sousse, TunisiaCardiology Department, Faculty of Medicine of Sousse, Sahloul Hospital, University of Sousse, Sousse, TunisiaCardiology Department, Faculty of Medicine of Sousse, Sahloul Hospital, University of Sousse, Sousse, TunisiaPrivate Clinic, Tunis, TunisiaCardiology A Department, Fattouma Bourguiba Hospital, Monastir, TunisiaCardiology A Department, Fattouma Bourguiba Hospital, Monastir, TunisiaCardiology Department, Faculty of Medicine of Tunis, Habib Thameur Hospital, University of Tunis, Tunis, TunisiaCardiology Department, Faculty of Medicine of Tunis, Habib Thameur Hospital, University of Tunis, Tunis, TunisiaCardiology Department, Faculty of Medicine of Tunis, Charles Nicolle Hospital, University of Tunis, Tunis, TunisiaCardiology Department, Faculty of Medicine of Sousse, Farhat Hached Hospital, University of Sousse, Sousse, TunisiaCardiology Department, Faculty of Medicine of Sousse, Farhat Hached Hospital, University of Sousse, Sousse, TunisiaCardiology Department, Faculty of Medicine of Sfax, Hedi Chaker Hospital of Sfax, University of Sfax, Sfax, Tunisia; The Tunisian Society of Cardiology and Cardiovascular Surgery, Tunis, TunisiaCardiology Department, Pasteur Clinic, Tunis, TunisiaCardiology Department, Faculty of Medicine of Tunis, Mongi Slim Hospital, University of Tunis, Tunis, TunisiaCardiology Department, Faculty of Medicine of Tunis, Mongi Slim Hospital, University of Tunis, Tunis, TunisiaCardiology Department, Faculty of Medicine of Tunis, Mongi Slim Hospital, University of Tunis, Tunis, TunisiaPrivate Clinic, Djerba, Medenine, TunisiaCardiology Department, Faculty of Medicine of Tunis, Menzel Bourguiba Hospital, University of Tunis, Bizerte, TunisiaCardiology Department, Pasteur Clinic, Tunis, TunisiaCardiology Department, Pasteur Clinic, Tunis, TunisiaCardiology Department, General & Cardiovascular Clinic, Tunis, TunisiaCardiology Department, Pasteur Clinic, Tunis, TunisiaCardiology Department, Carthage International Medical Center, Monastir, TunisiaThe Tunisian Society of Cardiology and Cardiovascular Surgery, Tunis, Tunisia; Cardiology Department, Habib Bourguiba Hospital, University of Sfax, Medenine, TunisiaCardiology Department, Pasteur Clinic, Tunis, TunisiaCardiology Department, Bassetine Clinic, Sfax, TunisiaCardiology Department, Bassetine Clinic, Sfax, TunisiaDACIMA Consulting, Tunis, TunisiaDACIMA Consulting, Tunis, TunisiaThe Tunisian Society of Cardiology and Cardiovascular Surgery, Tunis, Tunisia; Cardiology Department, Faculty of Medicine of Tunis, Mongi Slim Hospital, University of Tunis, Tunis, TunisiaThe Tunisian Society of Cardiology and Cardiovascular Surgery, Tunis, Tunisia; Cardiology Department, Faculty of Medicine of Sfax, Hedi Chaker Hospital of Sfax, University of Sfax, Sfax, TunisiaCardiology Department, Faculty of Medicine of Sfax, Hedi Chaker Hospital of Sfax, University of Sfax, Sfax, TunisiaCardiology Department, Hospital of the Interior Force Security, University of Tunis, Tunis, TunisiaCardiology Department, Pasteur Clinic, Tunis, Tunisia; The Tunisian Society of Cardiology and Cardiovascular Surgery, Tunis, TunisiaBackground: The prevalence of cardiac implantable electronic devices (CIEDs) in Tunisia is rising because of increased life expectancy and broader indications. This has led to a higher incidence of complications related to vascular access, device pockets, leads, and patient characteristics. Objective: We aimed to evaluate the prevalence, types, and predictors of complications occurring within the first year after CIED implantation and to profile the demographic and epidemiologic characteristics of CIED recipients in Tunisia. Methods: The National Tunisian Multicenter Prospective Study on Cardiac Implantable Electronic Devices is a nationwide, prospective study. We enrolled consecutive patients, from January 2021 to February 2022, undergoing de novo implantation of pacemakers, implantable cardioverter defibrillators, cardiac resynchronization therapy devices, generator replacements, and upgrading procedures. Patients attended 4 follow-up visits within the first year. Results: We enrolled 1500 patients with a mean age of 70.1 ± 15.2 years. Most (86.5%) received conventional pacemakers. The overall complication rate was 8.6%, with 129 complications in 80 patients. No significant associations were found between age or gender and complication rates. However, overweight and obesity were independent predictors of overall complications. Procedures performed in private health care settings were associated with a 56.2% reduction in complication rates. Generator replacements were linked to a 64.2% decrease in complication rates. Conversely, urgent or out-of-hours procedures increased the risk of complications by 62.7%. Procedures performed by non-electrophysiologist implanters were associated with an 89.5% increase in overall complication rates. Conclusion: Complications were more prevalent with cardiac resynchronization therapy devices. Identifying specific procedural predictors may pinpoint patients at higher risk, affecting personalized treatments and CIED implantation strategies.http://www.sciencedirect.com/science/article/pii/S2666501825001540TunisiaAfricaPacemakerImplantable cardioverter defibrillatorCardiac resynchronization therapyComplications |
| spellingShingle | Sonia Chabrak, MD Emna Allouche, MD Sana Ouali, MD Abdeddayem Haggui, MD Afef Ben Halima, MD Slim Kacem, MD Salma Krichen, MD Sonia Marrakchi, MD Wafa Fehri, MD Mohamed Sami Mourali, MD Zeineb Jabbari, MD Manel Ben Halima, MD Elyes Neffati, MD Aymen Heraiech, MD Mehdi Slim, MD Salem Kachboura, MD Habib Gamra, MD Majed Hassine, MD Sondes Kraiem, MD Sofien Kammoun, MD Leila Bezdah, MD Gouider Jridi, MD Hatem Bouraoui, MD Rania Hammami, MD Rafik Chettaoui, MD Youssef Ben Ameur, MD Fares Azaiez, MD Rami Tlili, MD Kais Battikh, MD Hedi Ben Slima, MD Rim Chrigui, MD Samia Fazaa, MD Islem Sanaa, MD Yassine Ellouz, MD Mohamed Mosrati, MD Sami Milouchi, MD Soumaya Jarmouni, MD Wacef Ayadi, MD Malek Akrout, MD Rabie Razgallah, MD Wissal Neffati, MD Meriem Drissa, MD Selma Charfeddine, MD Leila Abid, MD Lilia Zakhama, MD Salem Abdessalem, MD National Tunisian Multicenter Prospective Study on Cardiac Implantable Electronic Devices (Tunisian NATURE-CIED study): One-year complications and predictive factors Heart Rhythm O2 Tunisia Africa Pacemaker Implantable cardioverter defibrillator Cardiac resynchronization therapy Complications |
| title | National Tunisian Multicenter Prospective Study on Cardiac Implantable Electronic Devices (Tunisian NATURE-CIED study): One-year complications and predictive factors |
| title_full | National Tunisian Multicenter Prospective Study on Cardiac Implantable Electronic Devices (Tunisian NATURE-CIED study): One-year complications and predictive factors |
| title_fullStr | National Tunisian Multicenter Prospective Study on Cardiac Implantable Electronic Devices (Tunisian NATURE-CIED study): One-year complications and predictive factors |
| title_full_unstemmed | National Tunisian Multicenter Prospective Study on Cardiac Implantable Electronic Devices (Tunisian NATURE-CIED study): One-year complications and predictive factors |
| title_short | National Tunisian Multicenter Prospective Study on Cardiac Implantable Electronic Devices (Tunisian NATURE-CIED study): One-year complications and predictive factors |
| title_sort | national tunisian multicenter prospective study on cardiac implantable electronic devices tunisian nature cied study one year complications and predictive factors |
| topic | Tunisia Africa Pacemaker Implantable cardioverter defibrillator Cardiac resynchronization therapy Complications |
| url | http://www.sciencedirect.com/science/article/pii/S2666501825001540 |
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